Midatech updates its Bilbao factory
November 22, 2017Midatech Pharma , the international specialty pharmaceutical company focused on developing and commercialising products in oncology, has received formal notification from the Spanish regulatory authority AEMPS for an extension to its licence 6458E: Manufacturer of Investigational Medicinal Products, to include the manufacture of monodispersed controlled release microcapsules, marking the completion of the rigorous upscaling process conducted between November2016 and September 2017.
Midatech said that this licence amendment is required for the use of Midatech’s Sustained Release products manufactured at its Bilbao facility, including octreotide (MTD201) which is shortly due to commence clinical trials.
Dr Jim Phillips, Chief Executive Officer of Midatech Pharma, said: “The manufacturing facility in Bilbao continues to develop as a centre of excellence, currently producing all our human clinical stage products. This latest certification allowing GMP for our Q-Sphera products such as Q-Octreotide, allows us to continue our key programmes and to start preparing for commercial scale manufacture as our products get closer to filings with the FDA and other agencies.”